Welcome

Kuldev Singh, MD,  MPH - Professor of Ophthalmology at Stanford University

Opening Remarks from UCSF

Sam Hawgood, MD - Chancellor, University of California San Francisco (UCSF)

Opening Remarks from Stanford

Marc Tessier-Lavigne, PhD - President, Stanford University

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation: Advancing the Development, Approval and Surveillance of Medical Products

Kathy Giacomini, PhD - Co-Director of UCSF-Stanford CERSI

Keynote Address - The US Clinical Trial Ecosystem Is Deficient

Janet Woodcock, MD - Director, Center for Drug Evaluation and Research on detail to Operation Warp Speed and Principal Medical Advisor to the Commissioner at FDA

Moderated by Kathy Giacomini, PhD - Professor of Bioengineering and Therapeutic Sciences at UCSF

Panel 1 - Scientific Issues that Underlie the Development, Assessment, and Repurposing of Medical Products for Infectious Diseases

Moderators:

Robert M. Califf, MD - Head of Clinical Policy and Strategy for Verily and Google Health

Janet Woodcock, MD - Director, Center for Drug Evaluation and Research on detail to Operation Warp Speed and Principal Medical Advisor to the Commissioner at FDA

Panelists:

Diana Brainard, MD - Senior Vice President and Virology Therapeutic Area Head at Gilead Sciences

George Scangos, PhD - President and Chief Executive Officer of Vir Biotechnology

RADM Denise Hinton, MS - Chief Scientist at FDA

Peter Kim, PhD - Professor of Biochemistry at Stanford

Panel 2 - Accelerating the Development and Assessment of Novel Therapies for Cancer: What Is Needed

Moderators:

Laura Esserman, MD, MBA - Professor of Surgery and Radiology at UCSF

Peter Marks, MD, PhD - Director, Center for Biologics Evaluation and Research at FDA

Panelists:

Gideon Blumenthal, MD - Vice President of Global Regulatory Affairs for Oncology at Merck

Martha Donoghue, MD - Acting Deputy Director, Division of Oncology 2, Offices of Oncologic Diseases at FDA

John Tsai, MD - Head of Global Drug Development and Chief Medical Officer at Novartis 

George Yancopoulos, MD, PhD - Co-Founder, President and Chief Scientific Officer at Regeneron

Keynote Address - Advancing Bespoke Therapeutics

Peter Marks, MD, PhD - Director, Center for Biologics Evaluation and Research at FDA

Moderated by Kuldev Singh, MD, MPH - Professor of Ophthalmology at Stanford University

Lightning Talks in Regulatory Sciences

Room 1 - Moderator: Kuldev Singh, MD,  MPH - Professor of Ophthalmology at Stanford University

Speakers: 

Improving Precision and Power in Randomized Trials for COVID-19 Treatments Using Covariate Adjustment, for Binary, Ordinal, and Time-to-Event Outcomes - Michael Rosenblum, PhD - Associate Professor of Biostatistics at Johns Hopkins

The ISPY COVID Trial: Adapting Lessons Learned in Oncology to Combat the Pandemic - Carolyn Calfee, MD, Professor of Medicine at UCSF

Vaccine Platforms for Rapid Product Development - Wilbur Chen, MD, MS - Professor of Medicine at University of Maryland

Room 2 - Moderator: Laura Esserman, MD, MBA - Professor of Surgery and Radiology at UCSF

Speakers: 

Purposeful Trials - Clive Meanwell, MD, PhD - Executive Chairman of Population Health Partners

Studying SARS-COV-2 through an international collaboration - Nevan Krogan, PhD - Professor of Cellular and Molecular Pharmacology at UCSF

"Unconventional" Therapeutics: Host-Directed Anti-Infective Agents - Jason Sello, PhD - Professor of Pharmaceutical Chemistry at UCSF

Room 3 - Moderator: Kathy Giacomini, PhD - Professor of Bioengineering at Therapeutic Sciences at UCSF

Speakers:

Pediatric Drug Policies Supporting Safe And Effective Use of Therapeutics in Children - Florence Bourgeois, MD, MPH - Associate Professor of Pediatrics at Harvard

Quantifying Physical Function Using Wearables and Patient Reported Outcomes in Cancer Patients Undergoing Chemotherapy - Gita Thanarajasingham, MD - Assistant Professor of Medicine at Mayo Clinic

Hard to Control Diabetes State Preference for Islet Cell Transplant: FDA Biologics Sponsored Studies - Leslie Wilson, PhD - Professor of Clinical Pharmacy at UCSF

Panel 3 - Pandemic Preparedness: Lessons Learned from COVID-19

Moderators:

Joe DeRisi, PhD - Professor of Biochemistry and Biophysics at UCSF

Anne Wojcicki - CEO and Co-Founder of 23andMe

Panelists:

Amy Abernethy, MD, PhD - Principal Deputy Commissioner at FDA

Michael Drake, MD - President, University of California

Sam Hawgood, MD - UCSF Chancellor

Mark McClellan, MD, PhD - Professor of Business, Medicine and Health Policy at Duke

Jeff Shuren, MD, JD - Director of the Center for Devices and Radiological Health at FDA

Keynote Address - Update from CDRH

Jeff Shuren, MD, JD - Director of the Center for Devices and Radiological Health at FDA

Moderated by Laura Esserman, MD, MBA - Professor of Surgery and Radiology at UCSF

Panel 4 - Impact of the COVID-19 Pandemic on the Research, Development and Regulatory Review of Medical Products for Other Indications

Moderators: 

Jennifer Cochran, PhD - Chair of Bioengineering at Stanford

Andy Plump, MD, PhD - President, Research & Development at Takeda

Panelists:

Hal Barron, MD - Chief Scientific Officer at GlaxoSmithKline

Patrizia Cavazzoni, MD - Acting Director, Center for Drug Evaluation and Research at FDA

Mathai Mammen, MD, PhD - Global Head of Research and Development at Janssen Pharmaceutical Companies of Johnson & Johnson

Clive Meanwell, MD, PhD - Executive Chairman of Population Health Partners

George Yancopoulos, MD, PhD - Co-Founder, President and Chief Scientific Officer at Regeneron